- First patients dosed in KOMET-015 Phase 1 trial of ziftomenib for advanced GIST
- Potential solution for 60% of GIST patients developing resistance to imatinib
- Evaluates safety, tolerability, and antitumor activity in combination with imatinib
Kura Oncology, Inc. (KURA, Financial) announced the initiation of patient dosing in the KOMET-015 Phase 1 clinical trial. This trial evaluates the safety and efficacy of ziftomenib, a menin inhibitor, in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) who have shown resistance to prior imatinib treatment.
The KOMET-015 trial is a significant step, marking the first time a menin inhibitor is combined with the standard GIST treatment. The trial's main objectives are to assess safety and tolerability, establish the recommended Phase 2 dosing, and explore secondary endpoints like overall response rate and progression-free survival.
Each year, 4,000 to 6,000 new GIST cases are diagnosed in the U.S., with 60% of these patients developing resistance to imatinib within two years. Preclinical models have shown that the combination of ziftomenib and imatinib offers robust antitumor activity in both imatinib-sensitive and resistant GIST cases through a synthetic lethal mechanism.
This trial could potentially transform the treatment landscape for GIST, addressing the unmet need for patients who have limited options after developing resistance to existing treatments. The first patient dosing represents a crucial milestone in Kura's effort to expand the therapeutic use of ziftomenib beyond blood cancers into solid tumors.
